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Federal Register: Radiological Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting

July 28, 2010 6:33 am | by U.S. Food & Drug Administration | News | Comments

On 9/24/2010, the committee will discuss, make recommendations, and vote on a premarket approval application for the Selenia C Digital Breast Tomosynthesis System, sponsored by Hologic, Inc. The Selenia C Digital Breast Tomosynthesis System is intended...

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Bionovo, Inc. to Announce Second Quarter Fiscal Year 2010 Financial Results on Wednesday, August 4, 2010

July 28, 2010 6:33 am | by Bio-Medicine.Org | News | Comments

EMERYVILLE, Calif. , July 28 /- Bionovo, Inc. (Nasdaq: BNVI ) announced today that it will release financial results for the second quarter of fiscal year 2010 ended June 30, 2010 on Wednesday, August 4, 2010 . The Company will conduct a conference call and webcast to review the financial...

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Warner Chilcott Announces Earnings Release Date and Conference Call for Second Quarter 2010 Financial Results

July 28, 2010 6:33 am | by Bio-Medicine.Org | News | Comments

ARDEE, Ireland , July 28 /- Warner Chilcott plc (Nasdaq: WCRX) today announced that it will issue its second quarter 2010 financial results prior to the market opening on Friday, August 6, 2010 . In addition to issuing a press release, the Company will host a conference call for all...

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Curemark Opens Autism Trials at New Jersey Site

July 28, 2010 6:33 am | by Bio-Medicine.Org | News | Comments

RYE, N.Y. , July 28 /- Curemark, LLC ( www.curemark.com ), a drug research and development company focused on the treatment of neurological diseases, announced that Saint Peter's University Hospital in New Brunswick, New Jersey , is participating in the company's Phase III clinical trials...

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Washable, Wireless Mouse Prevents Cross-Contamination

July 28, 2010 6:23 am | Econo-Keys | Product Releases | Comments

Econo-Keys, a leading manufacturer of medical keyboards and mice, recently introduced the EKW-M, a completely waterproof, wireless mouse designed for the healthcare community.

Dyax numbers get boost from fees, drug sales

July 28, 2010 5:42 am | by Mass High Tech: The Journal of New England Technology | News | Comments

Cambridge-based biotech firm Dyax Corp. saw a surge in revenue for the second quarter, climbing to $15.1 million from $4.8 million for the same quarter in 2009. The bulk of that increase, $13.2 million, came from development and license fees.

Topaz Pharmaceuticals Announces Positive Data from Topical Ivermectin Trials Presented at Society of Pediatric Dermatology

July 28, 2010 5:39 am | by Bio-Medicine.Org | News | Comments

HORSHAM, Pa. , July 28 /- Topaz Pharmaceuticals Inc., a privately held biotechnology company, announced positive results of studies of topical ivermectin cream, which it is developing as a potential  treatment of Pediculus humanus capitis (head lice).   In a Phase 2 dose-ranging...

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Texas Health Plano, Texas Back Institute Offer SpineAssist Surgical Robot for Spine Surgeries

July 28, 2010 5:39 am | by Bio-Medicine.Org | News | Comments

Internationally renowned Plano surgeon co-invented technology PLANO, Texas , July 28 /PRNewswire-USNewswire/ -- Fifteen-year-old Tressa Scott of Allen hasn't been able to stand up straight for more than a year - until now. The Allen teenager grew an inch and a half and gained a...

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Accuray Incorporated to Report Financial Results for Fourth Quarter and Fiscal Year 2010

July 28, 2010 5:39 am | by Bio-Medicine.Org | News | Comments

SUNNYVALE, Calif. , July 28 /- Accuray Incorporated (Nasdaq: ARAY ), a global leader in the field of radiosurgery, today announced that it will report results for its fourth quarter and fiscal year 2010, ended June 30, 2010 on Tuesday, August 31, 2010 after the market closes. A conference...

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Baylor College of Medicine awarded $14.85 million grant to complete neurological research center at Texas Children's Hospital

July 28, 2010 5:38 am | by Baylor College of Medicine | News | Comments

Neurological research at Baylor College of Medicine and Texas Children's Hospital is getting a big boost in the form of a $14.85 million grant from the National Institutes of Health to complete two floors of the Jan and Dan Duncan Neurological Research Institute at Texas Children's...

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GTC Biotherapeutics flirts with profits in Q2

July 28, 2010 5:37 am | by Mass High Tech: The Journal of New England Technology | News | Comments

Framingham drug developer GTC Biotherapeutics Inc. cut its losses for the second quarter of the year to $300,000 against a loss of $10.8 million for the second quarter of 2009.

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Qualcomm Monitoring Health of Japanese Seniors

July 28, 2010 5:37 am | by San Diego Business Journal | News | Comments

In partnership with a Japanese corporation, Qualcomm Inc. said July 22 that it has embarked on an experiment to monitor the health of 300 elderly residents in rural Japan, including areas of snow-prone Hokkaido in the north.

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Intercept Pharmaceuticals to Collaborate With NIDDK on Study of Obeticholic Acid (INT-747) in Nonalcoholic Steatohepatitis (NASH)

July 28, 2010 5:36 am | by Bio-Medicine.Org | News | Comments

NEW YORK , July 28 /- Intercept Pharmaceuticals, Inc., a clinical stage biopharmaceutical company developing novel therapeutics for chronic fibrotic and metabolic diseases, today announced the signing of a cooperative research and development agreement (CRADA) with the National Institute...

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Integrating Quality by Design (Qbd) in Medical Device Manufacturing - Concept, Benefits and Challenging

July 28, 2010 4:57 am | by Igor Veljanovski, Stevens Institute of Technology | White Papers

The medical devices industry, as well as the pharmaceutical industry, is slowly butindisputably accepting the concept of Quality by Design into its design and developmentproduct phases, and is introducing the statistical tools and methods of the concept intoits process verification and validation phases as well. The Quality by Design concept orapproach has found its implementation in the medical devices life cycle management,under the guidance of risk regulations by the International Conference onHarmonization. Since the importance of successful implementation of this concept isever more evident in industry, this white paper will therefore discuss the concept and itspossible implementation in the medical devices industry, along with the benefits andconcerns expressed by the manufacturers.

EMD Serono, Inc.: FDA Grants Priority Review to Cladribine Tablets for the Treatment of Relapsing Forms of MS

July 28, 2010 2:35 am | by Bio-Medicine.Org | News | Comments

ROCKLAND, Mass. , July 28 /- EMD Serono, Inc., an affiliate of Merck KGaA, Darmstadt, Germany , announced today that the U.S. Food and Drug Administration (FDA) has accepted for filing the New Drug Application (NDA) for Cladribine Tablets as a therapy for relapsing forms of multiple...

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